Kornimate/medical-research-clean huggingface dataset:
an evaluation of pf-03715455 in moderate to severe chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study proposes to evaluate the safety and efficacy of pf-03715455 in subjects with moderate to severe chronic obstructive pulmonary disorder.


Eligibility criteria:
inclusion criteria: * female subjects of non-childbearing potential and male subjects between the ages of 40 and 80 years, inclusive * subjects with a diagnosis, for at least 6 months, of moderate to severe copd and who meet the criteria for stage ii-iii disease * subjects must have a smoking history of at least 10 pack-years exclusion criteria: * current evidence or history within the previous 6 months of any clinically significant disease (other than copd) or abnormality in the opinion of the investigator that would put the subject at risk or which would compromise the quality of the study data * a copd exacerbation requiring treatment with oral steroids or hospitalization for the treatment of copd within 3 months of screening

Keywords: copd sputum
oral progesterone and low dose aspirin in the prevention of preeclampsia

Conditions: Preeclampsia

Summary: this study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.

recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. these proteins can be measured and may be used to predict a woman's risk of developing preeclampsia. special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. these placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. human leukocytes antigen-g (hla-g) is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. recent studies have indicated that the level of hla-g is decreased in placentas from mothers with preeclampsia. progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of hla-g in the placental cytotrophoblast cells. in regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. this study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.

Eligibility criteria:
inclusion criteria: * pregnant patients with a previous history of preeclampsia in the immediate preceding pregnancy. * 18 to 45 years of age will be included. exclusion criteria: * patients with chronic hypertension * children (age \< 17 years) * patients that are currently taking anti-psychotics or selective serotonin re-uptake inhibitors * patients on medications which may be detrimental to the study interpretation will also be excluded at the principal investigator's discretion.

Keywords: preeclampsia progesterone aspirin prevent soluble fms-like tyrosine kinase (sflt-1) placental growth factor (plgf) risk
negotiation training for caregiver communication in ad

Conditions: Alzheimer Disease; Cognitive Impairment

Summary: the purpose of this study is to design a negotiation and dispute resolution (ndr) training intervention to improve communication and address resolution of conflicts that family caregivers of patients with cognitive impairment and/or alzheimer's disease (ad) frequently experience.

the goal of this study is to design a negotiation and dispute resolution (ndr) training intervention to improve communication and address resolution of conflicts that family caregivers of patients with cognitive impairment and/or alzheimer's disease (ad) frequently experience. specifically this study will: aim 1: employ a caregiver (user)-centered design approach to modify and tailor a negotiations and dispute resolution (ndr) training intervention to support communication skills of family caregivers of adults with ad. aim 2: utilizing multiphase optimization strategy (most), conduct a randomized controlled trial of the ndr intervention that targets better communication between caregivers and health teams to determine the feasibility of delivering the intervention, and derive estimates of the effect of 3 intervention components on changes in patient-centered outcomes at post-intervention and follow-up. exploratory aim 3: explore if intervention components (lectures/exercises) interact to change communication between caregivers and health care teams at post-intervention and follow-up.

Eligibility criteria:
inclusion criteria: * speak/read english; * currently provide care-giving support (e.g. emotional, social, physical, task-related) to an adult over the age of 65; * currently provide care-giving support at least 1 hour per week (e.g. may include grocery shopping, scheduling appointments, and transportation); * currently involved in any decision-making related to the healthcare and support of this adult over the age of 65; * score \>2 on the 8-item informant interview to differentiate aging and dementia (ad8); * access to and the ability to use the internet to complete a series of online activities; and * have a valid email address or the willingness to create one to access during the study exclusion criteria: * less than 21 years old * unable to speak and read english

Keywords: family caregiver negotiation dispute resolution conflict communication
a comparison between two techniques for performing decompressive craniectomy

Conditions: Brain Edema; Craniocerebral Trauma; Infarction, Middle Cerebral Artery

Summary: the purpose of this study is to compare two surgical techniques for a neurosurgical procedure used to treat cerebral edema (decompressive craniectomy): with watertight duraplasty vs. without watertight duraplasty (rapid closure decompressive craniectomy).

after clinical indication for unilateral decompressive craniectomy (dc), patients were randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group) vs. without watertight duraplasty / rapid closure dc (test group). in all cases, a large trauma flap (i.e. large reverse question mark starting from the tragus and extending to the midline) was performed. skin, galea and muscle layers were elevated according to surgeon preference. thus a wide (at least 12x15cm) craniotomy was performed and the temporal bone was removed until flush with the middle fossa floor. after dural opening, watertight duraplasty with pericranium or an artificial graft (at surgeon's discretion) was performed in the control group, while no watertight duraplasty was performed in the test group, and exposed brain parenchyma was covered with surgicel®. usual closure was then performed. patients were then monitored daily by evaluators blinded to the randomization (control or test group) from the date of surgery until hospital discharge or death.

Eligibility criteria:
inclusion criteria: * patients admitted to the neurotrauma service of the hospital of restoration from january 2012 to december 2013, age range 18 to 60 years old and with clinical indication for decompressive craniectomy. exclusion criteria: * indication for bifrontal decompressive craniectomy. * indication for posterior fossa decompressive craniectomy * patients with intra-axial contusions or hematomas requiring surgical evacuation in which case injury to the arachnoid could lead to an increased risk of cerebrospinal fluid leak

Keywords: decompressive craniectomy brain edema
effectiveness of osteopathic manipulative treatment in nicu: a multicenter clinical trial

Conditions: Prematurity

Summary: the use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. this integrated medicine approach has been shown to be helpful to improve neonatal health care. osteopathic manipulative treatment (omt) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. results from previous studies documented the positive association between omt and shorter period of hospitalisation as well as improvement of clinical conditions. the aim of this nationwide multicenter study is to demonstrate the effect of omt on length of stay (los) in premature infants across 3 neonatal intensive care units (nicu).


Eligibility criteria:
inclusion criteria: * preterm infants born at age between 29 and 37 weeks * osteopathic treatment performed \< 14 days after birth * preterms born in the same hospital exclusion criteria: * gestational age \< 29 weeks * gestational age \> 37 weeks * first omt performed after 14 days from birth * genetic disorders * congenital disorders * cardiovascular abnormalities * proven or suspected necrotized enterocolitis with or without gastrointestinal perforation * proven or suspected abdominal obstruction * pre/post surgery patients * pneumoperitoneum * atelectasis * newborn from an hiv seropositive/drug addicted mother * respiratory disorders * transferred to/from other hospital * admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

Keywords: prematurity omt complementary and alternative medicine neonates length of stay
diaphragm activity during incentive spirometry and diaphragmatic breathing

Conditions: Diaphragm Mobility; Breathing Exercises; Incentive Spirometry; Diaphragmatic Breathing

Summary: the objective of the present study is to evaluate diaphragm activity during three breathing exercises: diaphragmatic breathing (db), flow-oriented (triflo ii)incentive spirometry and volume-oriented (voldyne) incentive spirometry. seventeen healthy subjects will be studied (8 man and 9 woman).

right diaphragmatic mobility will be evaluated by determining the craniocaudal displacement of the left branch of the portal vein using a b-mode ultrasound device (logic 500, pro series®; general electricmedical systems, milwaukee, wi, usa). the ultrasound technician will use a 3.5 mhz convex transducer positioned in the right subcostal region, with the incidence angle perpendicular to the craniocaudal axis, in the direction of the inferior vena cava. next, an intraparenchymal portal branch will be identified in the field of vision and its position will be traced with the curser during the forced inspiration and expiration. the craniocaudal displacement of these points will be considered to be the amount of right diaphragmatic mobility.

Eligibility criteria:
inclusion criteria: * being 18 to 40 years old * having a normal body mass index * being a non-smoker * not knowing the db and the is techniques * reporting the absence of respiratory diseases. exclusion criteria: * presenting alteration in respiratory function detected by functional analysis of lung volume and capacity * inability to understand or perform the procedure.

Keywords: incentive spirometry diaphragm mobility ultrasound diaphragmatic breathing
evaluation of therapeutic video games for pre-school children with acute lymphoblastic leukemia

Conditions: Childhood Lymphoblastic Lymphoma

Summary: the purpose of this study is to evaluate the effectiveness of therapeutic video game.

children cancer was the third-ranked causes of children's death. during the long treatment courses, children are always forced to accept lots of drug therapy and invasive procedures without understanding the medical purpose. due to the immature cognition, always lead to anxiety in childhood cancer patients. our team developed a mobile technology platform based therapeutic video game (tvg) for preschoolers with acute lymphoblastic leukemia (all) in early 2018. then three clinical experts were invited to validate tvg and had high appropriateness consensus. then the pilot study was conducted in one medical center in taipei and 10 preschoolers with all had been randomly signed in two groups-5 to intervention group (6 weeks game intervention) and 5 to control group (regular care). the preliminary results showed that crying scale and resisting behavior were no significance between two groups in the initial period (p=.663), but the intervention group showed lower crying grades and less resisting behavior than the control group in the final period (p=.028). the limitation of this pilot research was small sample size and short intervention time. therefore, the purpose of this study is to increase the sample size and intervention time to evaluate the effectiveness of our tvg. methods: a total of 68 fresh all preschool children will be randomized divided equally into intervention group and control group. only intervention group

Eligibility criteria:
inclusion criteria: * all exclusion criteria: * non tpog therapy * without port-a * under pbst treatment * all recurrent * mental retardation

Keywords: acute lymphoblastic leukemia therapeutic video games childhood cancer preschoolers anxiety resisting behavior
antipsychotic effects of oxytocin

Conditions: Schizophrenia

Summary: the objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.

this is two-site clinical study taking place at ucsd and uci. approximately 71 patients at each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this site. the total duration for each individual subject will be 6 weeks on study medication (placebo or oxytocin).

Eligibility criteria:
inclusion criteria: * adult men or women, 21 years of age or older. * meet dsm-iv criteria for schizophrenia. * women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study. * must be on a therapeutic dose of an atypical antipsychotic medication (examples but not limited to clozapine olanzapine, risperidone, ziprasidone, aripiprazole, seroquel) with no major dose changes for at least 4 weeks. * a minimum panss total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the panss (suspiciousness/persecution) at screening. * have a clinical global impressions-severity (cgi-s) scale score of at least 4 (moderately ill) at baseline. * must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent. * must be able to use nasal spray. * must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator. exclusion criteria: * are pregnant or are breastfeeding (negative pregnancy test at screening). * a urine drug screen performed at screening must not show evidence of recent use of drugs of abuse. * any active medical condition that in the opinion of the investigator will interfere with the objectives of the study. * are unsuitable in any way to participate in this study, in the opinion of the investigator. * another current dsm-iv diagnosis other than schizophrenia. permitted: * subjects on one ssri, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study. minor adjustments in sleep medication are acceptable. patients will be asked to notify the study doctor of any changes to sleep aids.

Keywords: oxytocin
a pilot study assessing the effect of lymphaticovenous micro-anastomosis in the treatment of postmastectomy lymphedema

Conditions: Lymphedema; Post Mastectomy

Summary: this study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. we hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with post-mastectomy lymphedema


Eligibility criteria:
inclusion criteria: * subject is 18-70 years of age * subject is stage ii-iv unilateral lymphedema exclusion criteria: * subject is less than 6 months from completion of cancer treatment * subject has allergic reaction to the lymphatic contrast agent (indocyanine blue) * subject is medically unfit for the procedure * subject is unable to complete the follow-up visits * women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence. * subject has bilateral lymphedema
assessment of repeat ascending doses of gsk2018682 in healthy volunteers

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat ascending doses of gsk2018682. the study will also provide further evidence of the potential therapeutic dose-range by measuring the inhibitory effect of gsk2018682 on absolute lymphocyte counts (alc).

the study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat ascending doses of gsk2018682. the study will also provide further evidence of the potential therapeutic dose-range by measuring the inhibitory effect of gsk2018682 on absolute lymphocyte counts (alc).

Eligibility criteria:
inclusion criteria: * healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * females must be of non-childbearing potential. * bmi within the range 19 - 29 kg/m2 (inclusive). exclusion criteria: * a positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of screening * current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones). * a positive pre-study drug/alcohol screen. * a positive test for hiv antibody. * history of regular alcohol consumption within 6 months of the study. * the subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * exposure to more than four new chemical entities within 12 months prior to the first dosing day. * use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including st john's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and gsk medical monitor the medication will not interfere with the study procedures or compromise subject safety. * history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or gsk medical monitor, contraindicates their participation. * were participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period. * pregnant females as determined by positive serum or urine hcg test at screening or prior to dosing. * unwillingness or inability to follow the procedures outlined in the protocol. * other exclusion criteria to be detailed at the time of physical screening by the investigator

Keywords: pharmacodynamics pharmacokinetics
level and degree of spinal cord injury and its impact on male sexual function

Conditions: Spinal Cord Injury

Summary: in addition to the motor and sensory functions, sexual function changes after spinal cord injury and is considered one of the most common problems, ranging from a decrease in sexual desire to disturbances of erection, orgasm and ejaculation. objective: to assess the impact of the complexity of traumatic spinal cord injury in male sexual function.

methods: observational study (ceac 41221414.5.0000.5208) conducted with 45 men, mean age 34 (ci 31.5 to 37.1), with spinal cord injury and active sex life. sexual function was assessed by the international index of erectile function (iief) and level and degree of injury were determined following the guidelines of the international standards for neurological and functional examination classification of spinal cord injury. data were collected after at least six months of injury in referral hospitals. descriptive statistics and bivariate analysis were applied to observe the association between sexual function and complexity of the lesion, with a 0.05 significance level.

Eligibility criteria:
inclusion criteria: * men * aged between 18 and 60 years * clinical diagnosis of traumatic spinal cord injury * injury time equal to or greater than six months * heterosexual * sexually active. exclusion criteria: * patients with erectile dysfunction attributed to endocrine or metabolic disease order * those who underwent surgery as radical prostatectomy or penile implant * cognitive impairment.

Keywords: sexuality spinal cord injuries penile erection erectile dysfunction
nibp (non-invasive blood pressure) algorithm enhancements (characterize the robustness of motion artifact suppression)

Conditions: Movement, Involuntary

Summary: the study intervention consists of a non-invasive blood pressure (nibp) measurement device and cuff (fda-cleared philips intellivue x3 rev. n.04 patient monitor) running a non-approved modified software containing an enhanced measurement algorithm for nibp.

the purpose of this study is to compare measurements of nibp taken by the study device and measurements taken by the current fda-approved algorithm included in rev. n.0 software for the intellivue patient monitors during motion artifact in patients undergoing caesarian section deliveries under epidural anesthesia.

Eligibility criteria:
inclusion criteria: * obstetric patient at yale new haven hospital * receiving epidural anesthesia * age at least 18 years * willing and able to provide informed consent in a sponsor approved language * willing and able to comply with study-related procedures * priority classification ii, iii, or iv exclusion criteria: * non-caesarian section deliveries * ruptured uterus, prolonged fetal bradycardia, cord prolapse, or other emergent condition * procedures under general anesthesia * altered mental status * currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s) * priority classification i or v